AAI Pharma and CML merged in 2013​, to form a full-service contract manufacturing organisation (CMO) and two-and-a-half years on the firm has said the integration between the two units has led to “dramatic advancements in efficiency.”​

According to the CMO, it has managed to manufacture and release late-stage clinical trial materials from an active pharmaceutical ingredient (API) made under GMP, through to the sterile drug product within 79 days.

This is around 65% of the 230 days AAI/CML said is the industry standard for non-integrated approaches, and marks the first time the company has produced both GMP API and GMP Drug Product in continuous end-to-end fashion.

“We have streamlined and integrated to create world class solution for small to mid-sized pharma & biotech companies for clinical trial material by providing a broad range of services across all seven of our sites and businesses,”​ CEO Stephan Kutzer said in a statement.

“Our technical and regulatory expertise differentiates AAI/CML as we proactively guide and advise our clients through all the clinical phases. The integrated manufacturing services further complement our ProForm SelectTM service offering for a fuller end-to-end solution.”​

The announcement comes weeks after the CMO announced it was investing $11m (€10m)​ into a new facility at its Cortex innovation centre in St Louis, Missouri.